kebaldwin
Wed, Aug-17-05, 15:59
FDA refuses to pull Abbott obesity drug Wed Aug 17, 1:19 PM ET
The U.S. Food and Drug Administration rejected a consumer group's petition to withdraw Abbott Laboratories Inc.'s obesity drug Meridia but said it would continue to watch for safety problems, according to documents released on Wednesday.
Consumer advocacy group Public Citizen had twice called on the agency to pull the drug -- also known as sibutramine -- from the market, citing deaths from cardiovascular problems in people using the drug.
But the FDA concluded that "sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients," wrote Steven Galson, head of the agency's drug division.
Galson added that the agency had worked with Abbott to educate doctors about appropriate patients and to change the drug's label, adding the need to monitor patients' blood pressure.
Meridia is an appetite suppressant approved in 72 countries to treat obese adults along with dieting, according to the FDA. It can cause side effects ranging from headaches and constipation to higher blood pressure and a faster heart rate.
Public Citizen's Health Research Group Director Sidney Wolfe said the 50 heart-related deaths reported since the drug's approval still warrant its removal. While Meridia use has dropped, "many people are still getting this dangerous but not very effective drug," said Wolfe, whose group petitioned for the ban in 2002 and again in 2003.
Abbott, in a statement, criticized Public Citizen's analysis and said Meridia had repeatedly been proven safe and effective.
Long term effects of the drug on obesity-related death is still unknown, according to the drug's label.
Weight-loss drugs are a growing market and have added to the debate over whether obesity is itself a disease and how to treat it. Nearly two-thirds of Americans are overweight or obese, which can raise the risk of diabetes, heart disease, certain types of cancer, and other diseases.
Some advocates say many patients cannot shed pounds without medicine. But critics say the benefits of small weight loss through these drugs are not worth the risks, which can include heart problems, nausea and vomiting.
Meridia is one of five approved drugs that FDA veteran scientist David Graham said should be scrutinized when he spoke at a congressional hearing last year.
On Wednesday, Graham said the FDA and the company were "relying on statistics" to keep the drug on the market. While studies show Meridia can help patients lose some pounds, the loss is not enough to improve patients' health, he said.
"What's the health benefit of losing 15 pounds if you weigh 300 pounds? There is none," Graham said. Because of the side effects, he said a study he did three years ago showed most patients stayed on the drug for less than a month
http://news.yahoo.com/s/nm/20050817/hl_nm/abbott_meridia_dc;_ylt=AmmifvqCqb8yL3.sYK67BDjVJRIF;_ylu=X3oDMTBiMW04NW9mBHNlYwMlJVRPUCUl
The U.S. Food and Drug Administration rejected a consumer group's petition to withdraw Abbott Laboratories Inc.'s obesity drug Meridia but said it would continue to watch for safety problems, according to documents released on Wednesday.
Consumer advocacy group Public Citizen had twice called on the agency to pull the drug -- also known as sibutramine -- from the market, citing deaths from cardiovascular problems in people using the drug.
But the FDA concluded that "sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients," wrote Steven Galson, head of the agency's drug division.
Galson added that the agency had worked with Abbott to educate doctors about appropriate patients and to change the drug's label, adding the need to monitor patients' blood pressure.
Meridia is an appetite suppressant approved in 72 countries to treat obese adults along with dieting, according to the FDA. It can cause side effects ranging from headaches and constipation to higher blood pressure and a faster heart rate.
Public Citizen's Health Research Group Director Sidney Wolfe said the 50 heart-related deaths reported since the drug's approval still warrant its removal. While Meridia use has dropped, "many people are still getting this dangerous but not very effective drug," said Wolfe, whose group petitioned for the ban in 2002 and again in 2003.
Abbott, in a statement, criticized Public Citizen's analysis and said Meridia had repeatedly been proven safe and effective.
Long term effects of the drug on obesity-related death is still unknown, according to the drug's label.
Weight-loss drugs are a growing market and have added to the debate over whether obesity is itself a disease and how to treat it. Nearly two-thirds of Americans are overweight or obese, which can raise the risk of diabetes, heart disease, certain types of cancer, and other diseases.
Some advocates say many patients cannot shed pounds without medicine. But critics say the benefits of small weight loss through these drugs are not worth the risks, which can include heart problems, nausea and vomiting.
Meridia is one of five approved drugs that FDA veteran scientist David Graham said should be scrutinized when he spoke at a congressional hearing last year.
On Wednesday, Graham said the FDA and the company were "relying on statistics" to keep the drug on the market. While studies show Meridia can help patients lose some pounds, the loss is not enough to improve patients' health, he said.
"What's the health benefit of losing 15 pounds if you weigh 300 pounds? There is none," Graham said. Because of the side effects, he said a study he did three years ago showed most patients stayed on the drug for less than a month
http://news.yahoo.com/s/nm/20050817/hl_nm/abbott_meridia_dc;_ylt=AmmifvqCqb8yL3.sYK67BDjVJRIF;_ylu=X3oDMTBiMW04NW9mBHNlYwMlJVRPUCUl